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Caspofungin acetate - Generic Drug Details

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Caspofungin acetate is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-three patent family members in forty-seven countries.

There are seven drug master file entries for caspofungin acetate. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: caspofungin acetate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packaging: see list1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: caspofungin acetate

Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal

Tentative approvals for CASPOFUNGIN ACETATE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION50MG/VIAL
<disabled><disabled>INJECTABLE; INJECTION70MG/VIAL
<disabled><disabled>INJECTABLE;INJECTION50MG

Clinical Trials for: caspofungin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 2001RXYes6,136,783*PED<disabled>Y<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 2001RXYes5,952,300*PED<disabled>Y<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 2001RXYes5,514,650*PED<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: caspofungin acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 20015,378,804*PED<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 20015,378,804*PED<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 20015,792,746*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: caspofungin acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,792,746 Aza cyclohexapeptide compounds<disabled in preview>
5,378,804 Aza cyclohexapeptide compounds<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: caspofungin acetate

Country Document Number Estimated Expiration
Germany69722615<disabled in preview>
Bulgaria63047<disabled in preview>
Cyprus2374<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CASPOFUNGIN ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036France<disabled>PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C0054France<disabled>PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
/2001Austria<disabled>PRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024
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